论著

补肾益气方肾俞膏摩治疗结直肠癌康复期癌因性疲乏的临床观察及疗效评价:一项随机对照试验

Clinical observation and curative effect evaluation of Shenshu Tuina combined with Bushen Yiqi herbal ointment on cancer-induced fatigue in convalescent stage of colorectal cancer

:333-340
 
       目的  观察补肾益气方肾俞膏摩治疗结直肠癌康复期癌因性疲乏的临床疗效。方法  收集2023年6月—2024年6月结直肠癌康复期的80例住院及门诊患者,随机平均分为两组。行常规对症支持治疗的为对照组;在常规对症支持治疗上加用补肾益气方肾俞膏摩的为干预组;两组均连续治疗14天。于开始治疗前1天和治疗结束后1天分别进行疗效评估相关指标检测。于治疗前1天、治疗第7天和第14天进行不良反应检测。结果 干预组治疗后Piper评分、中医证候总积分、PSQI评分、KPS评分及免疫功能指标(CD3+  、CD4+、CD8+  、CD4+ /CD8+ )较治疗前均有明显改善;干预组发生不良反应少于对照组。结论  补肾益气方肾俞膏摩治疗能够有效改善结直肠癌患者的癌因性疲乏的治疗效果,提高生活质量和免疫功能,减少不良反应。
       Objective  To observe the clinical observation of Shenshu Tuina combined with Bushen Yiqi herbal ointment in the treatment of cancer-induced fatigue in the convalescent stage of colorectal cancer and evaluate the efficacy.Methods  From June 2023 to June 2025,80 inpatients and outpatients of colorectal cancer in the  recovery period were collected and  randomly divided into two groups.The patients who received routine symptomatic supportive treatment were enrolled as the control group.The intervention group was given Shenshu Tuina combined with Bushen Yiqi herbal ointment on the basis of control group.The relevant indicators for efficacy evaluation were tested one day before treatment and one day after the end of treatment.Adverse reactions were detected on the day before treatment,theseventh day and 14th day during treatment.Results  The efficacy evaluation indexes of the intervention group after treatment were obviously improved compared with those before treatment.Adverse  reactions occurred less in the intervention group than in the control group.Conclusions  Shenshu Tuina combined with Bushen Yiqi herbal ointment can effectively improve the treatment effect of cancer-induced fatigue in patients with colorectal cancer,improve the quality of life and immune function,reduce adverse reactions.
论著

超声引导下针刺蝶腭神经节治疗过敏性鼻炎的随机对照研究

Ultrasound-guided acupuncture at the sphenopalatine ganglion for the treatment of allergic rhinitis:A randomized controlled study

:105-110
 
       目的   观察超声引导下针刺蝶腭神经节治疗过敏性鼻炎的临床疗效。方法   将80例过敏性鼻炎患者随机分成干预组(40例)和对照组(40例),干预组采用超声引导针刺蝶腭神经节,对照组采用常规方法针刺蝶腭穴,每周2次,持续4周。结果   治疗4周后,干预组和对照组均显示出良好疗效。干预组的总有效率为92.50%,对照组的总有效率为82.50%,差异有统计学意义(P<0.05);干预组在鼻症状总分(TNSS)、非鼻症状总分(TNNSS)、视觉模拟量表(VAS)和鼻结膜炎生活质量问卷(RQLQ)等指标上的改善均优于对照组(P<0.05)。结论   超声引导下针刺蝶腭神经节治疗过敏性鼻炎能有效改善患者的临床症状。
   Objective  To investigate the main clinical effect of acupuncture of pterygopalatine ganglion on patients with allergic rhinitis under the guidance of ultrasound.Methods  A total of 80 patients with allergic rhinitis were randomly divided into intervention group and control group.The intervention group was treated with ultrasound guided acupuncture of the sphenopalatine 
ganglion,the control group was treated with conventional acupuncture at sphenopalatine point.The clinical efficacy was determined after the course of treatment.Results  The total effective rate was 92.50% in the intervention group and 82.50% in the control group.The improvement of total nasal symptom score,total non-nasal symptom score,VAS and Arhinoconjunctivitis Quality of Life Questionnaire scores in the treatment group was significantly better the control group Conclusions  Ultrasound-guided acupuncture of the sphenopalatine ganglion can improves clinical symptoms of patients with allergic rhinitis.
论著

中医药治疗儿童哮喘随机对照试验结局指标现状

Current status of outcome indicators of randomized controlled trials of traditional Chinese medicine for the treatment of childhood asthma

:1531-1541
 
       目的   剖析中医药治疗儿童哮喘的随机对照试验(RCT)结局指标,为中医药治疗该病临床试验的核心指标集构建提供初步依据。方法   检索中国知网(CNKI)、万方(WanFang)、维普网(VIP)、中国生物医学文献数据库(SinoMed)、PubMed、Cochrane Library、EmBase、Web of Science。时间跨度为建库至2024年7月1日。此次检索全面覆盖了中医药疗法治疗儿童哮喘的临床随机对照研究,由两名研究者根据纳排标准独立完成文献筛选和资料提取,提取文献基本特征和结局指标。结果   初步检索出2 449篇文献,最终纳入165个RCT,包括205个结局指标,分为症状/体征、中医症状/证候、理化检查、生活质量评价、远期预后、安全性指标六域。结论   中医药治疗儿童哮喘尚存在中医证候诊断和疗效标准不完善、主要和次要结局指标界限不清等问题,应当构建统一规范且广为认可的核心指标集,以促进儿童哮喘核心指标集的完善。
        Objective  To analyze the outcome indicators of randomised controlled trials(RCTs)of traditional Chinese medicine(TCM)for the treatment of childhood asthma,and to provide a preliminary basis for the construction of a core set of indicators for clinical trials of TCM for the treatment of this disease.Methods  A database search was conducted on China Knowledge Network(CNKI),WanFang,VIP,SinoMed,PubMed,Cochrane Library,EmBase,and Web of Science,covering the period from the establishment of the database to 1 July 2024.The search comprehensively covered clinical randomised controlled studies of TCM therapies in the treatment of childhood asthma,and was completed independently by two investigators who screened the literature and extracted information according to the criteria,and extracted the basic characteristics of the literature and outcome indicators.Results  Initially,2 449 literatures were retrieved,and 165 RCTs were finally included,including 205 outcome indicators,which were classified into six domains:symptoms/signs,TCM symptoms/evidence,physical and chemical examination,quality of life evaluation,long-term prognosis,and safety indicators.Conclusions  Currently,there are problems such as imperfect diagnostic and efficacy criteria for TCM evidence,and unclear boundaries between primary and secondary outcome indicators in the treatment of childhood asthma with TCM.A unified,standardised and widely recognised core indicator set should be constructed to promote the improvement of the core indicator set for childhood asthma.
论著

一次性使用电子宫腔镜与可重复使用宫腔镜用于门诊宫腔镜检查的多中心随机对照研究

A multicenter randomized controlled study of single-use digital hysteroscope versus reusable hysteroscope for outpatient hysteroscopy

:16-22
 
目的 比较采用一次性使用电子宫腔镜与可重复使用宫腔镜用于门诊宫腔镜检查的有效性与安全性。方法 采用平行随机对照的方法,在3间临床试验研究机构同时进行,一次性使用电子宫腔镜用于宫腔镜检查者82例为试验组,Storz Bettochi检查镜进行检查者82例为对照组。记录2组患者宫腔影像的临床诊断符合率、操作性能评分、不良事件发生率。结果 试验组临床诊断要求符合率98.8%(80/82),对照组临床诊断要求符合率100%(82/82);试验组与对照组宫腔影像的临床诊断要求符合率的差值为-1.22%,试验组和对照组符合率差值的95%可信区间下限为-3.60%,大于非劣效界值-10.00%。试验组与对照组之间的操作性能评分比较差异无统计学意义(P>0.05)。试验组不良事件发生率11.0%(9例,9件),严重不良事件发生率1.2%(1例,1件);对照组中不良事件发生率9.8%(8例,9件),严重不良事件发生率0%(0例,0件);不良事件发生率和严重不良事件发生率的组间比较差异均无统计学意义(P>0.05)。结论 一次性使用电子宫腔镜用于提供患者子宫内图像,整体性能与可重复使用的电子宫腔镜相当,并且安全性好。试验用一次性使用电子宫腔镜的使用性能可满足临床宫腔镜手术的需求,可作为宫腔镜技术的补充手段。
Objective To compare the efficacy and safety of single-use digital hysteroscope and reusable hysteroscope for outpatient hysteroscopy.Methods A parallel randomized control method was used in three clinical trials institutions.Eighty-two cases of outpatient patients who used single-use digital hysteroscope for hysteroscopy were included in experimental group,and 82 cases who underwent hysteroscopy by reusable hysteroscope(Storz Bettochi)were included in control group.The clinical diagnosis coincidence rate,performance score and incidence of adverse events of uterine imaging were recorded in the two groups.Results The coincidence rate of clinical diagnosis in the experimental group was 98.8%(80/82),1.22% lower than the 100%(82/82)in control group.And the difference of lower limit of 95% confidence interval between the experimental group and the control group was-3.60%,which was greater than the non-inferiority margin-10.00%.There was no significant difference in performance scores between the experimental group and the control group(P>0.05).The incidence of adverse events in the experimental group was 11.0%(9 cases,9 events),and serious adverse events incidence was 1.2%(1 case,1 event).In the control group,the incidence of adverse events was 9.8%(8 cases,9 events),and no serious adverse events occurred(0 cases,0 events).There was no significant difference in the incidence of adverse events or serious adverse events between two groups.Conclusions The overall performance of single-use digital hysteroscope for providing intrauterine images,observation and diagnosis is comparable to that of reusable hysteroscope,and the safety is also comparable.The performance of the single-use digital hysteroscope can meet the needs of outpatient hysteroscopy,and it can be an effective supplementary hysteroscopy technology.
论著

心脉通治疗冠心病临床随机对照试验的系统评价

Systematic review of clinical randomized controlled trials of Xinmaitong in the treatment of coronary heart disease

:118-124
 
目的 系统评价心脉通治疗冠心病的临床疗效及其安全性。方法 2名研究者独立系统地检索心脉通治疗冠心病的文献,其中包括维普中文科技期刊全文数据库(VIP)、PubMed 电子期刊全文数据库、中国学术期刊全文数据库(CNKI)、The Cochrane Library 数据库、万方数据库等6个数据库。同时运用Review Manager 5.4 软件进行本研究的数据处理。结果 最终共纳入8篇文献,共计985名心脉通治疗冠心病患者。治疗前后的临床疗效、发作频率、血脂水平的Meta分析结果显示心脉通组优于常规治疗组。有3项纳入试验报告不良反应。结论 心脉通治疗冠心病的临床疗效优于常规治疗。心脉通不仅可以降低冠心病发作频率,缩短其发作持续时间,还能调节血脂水平,在治疗冠心病方面疗效确切,值得临床参考应用。
Objective To systematically evaluate the clinical efficacy and safety of Xinmaitong in the treatment of coronary heart disease (CHD). Methods Two researchers searched the literatures of Xinmaitong in the treatment of coronary heart disease independently and systematically, including VIP Chinese Sci-tech Journal full-text Database (VIP), PubMed Electronic Journal full-text Database, Chinese Academic Journal full-text Database (CNKI), The Cochrane Library Database and Wanfang Database. At the same time, Review Manager 5.4 software was used to process the data of this study. Results A total of 8 articles were included, and a total of 985 patients with coronary heart disease were treated with Xinmaitong. The results of Meta analysis of clinical efficacy, attack frequency and blood lipids level before and after treatment showed that Xinmaitong group was better than routine treatment group. Three items were included in the report of adverse reactions. Conclusions The clinical effect of Xinmaitong in the treatment of coronary heart disease was better than that of routine treatment. Xinmaitong can not only reduce the frequency and duration of coronary heart disease attack, but also regulate blood lipids level. Xinmaitong was effective in the treatment of coronary heart disease and is worthy of clinical reference.
论著

小剂量右美托咪定改善臂丛神经阻滞效果的随机对照研究

Low dose of dexmedetomidine as an adjunction to ropivacaine in supraclavicular brachial plexus block: a randomized controlled trial

:20-26
 
目的 观察右美托咪定作为佐剂对罗哌卡因在锁骨上入路臂丛神经阻滞效果的影响。方法 将55例上肢择期手术的受试者随机分为右美组和对照组。右美组:30 μg右美托咪定(0.3 mL)+0.5%罗哌卡因,对照组:生理盐水(0.3 mL)+0.5%罗哌卡因。在臂丛神经阻滞操作后,按步骤评估和记录臂丛感觉、运动阻滞程度和起效时间。在术中定期监测和记录生命体征、不良事件的发生。手术后评估和记录术毕24小时生命体征、术后镇痛时间、臂丛神经感觉、运动阻滞的持续时间、术后恶心呕吐评分、补救镇痛药物用量和不良事件等数据。结果 在臂丛神经的感觉和运动起效时间、感觉和运动阻滞持续时间、术后镇痛时间方面,右美组长于对照组,存在统计学差异(P<0.05)。两组间在术后生命体征变化、补救镇痛药物用量、术后恶心呕吐评分、不良事件等数据的比较,未见明显统计学差异(P>0.05)。结论 右美托咪定(30 μg)作为佐剂能加快罗哌卡因在锁骨上入路对臂丛神经阻滞的起效时间,增加其术后镇痛时间和对臂丛神经的感觉、运动阻滞时间,同时较少影响患者生命体征,具备一定的有效性和临床安全性。
Objective To observed the effect of dexmedetomidine as an adjunction with ropivacaine in supraclavicularbrachial plexus block. Methods 55 subjects with elective upper extremity operation were randomly divided into two groups: DEX group and control group. The drugs in DEX group was 30 μg dexmedetomidine (0.3 mL) + 0.5% ropivacaine, 20 mL in total. And the one in control group was normal saline (0.3 mL) +0.5% ropivacaine, 20 mL in total. After the operation of brachial plexus block, the value of sensory and motor block of brachial plexus and the onset time were evaluated and recorded according to the protocol. Vital signs and adverse events were monitored and recorded regularly during the operation.Postoperative vital signs, postoperative analgesia time, duration of brachial plexus sensationsensory and motion block, postoperative nausea and vomiting score, dosage of remedial analgesics and adverse events were assessed and recorded in 24 hours after surgery. Results In terms of sensory and motor onset time of brachial plexus, duration of sensory and motor block and postoperative analgesia, DEX group was longer than the control group, with statistical differences (P<0.05).There were no significant statistical differences between the two groups in postoperative vital signs, the amount of remedial analgesic drugs, postoperative nausea and vomiting scores, adverse events etc(P>0.05). Conclusion As an adjuvant, dexmedetomidine (30 μg) can accelerate the onset time of ropivacaine in the supraclavicular approach of brachial plexus block.It can also increase the postoperative analgesia time and sensory and motor block time of brachial plexus.With less impact on the vital signs of patients, the efficacy and clinical safety of dexmedetomidinecan be found in our study.
临床诊疗

补肾养骨口服液对强直性脊柱炎的疗效与安全性:随机对照试验

:119-122
 
目的 本研究探讨补肾养骨口服液对强直性脊柱炎的疗效及其安全性。方法 本研究为随机对照试验,研究了补肾养骨口服液+塞来昔布胶囊对比单纯用塞来昔布胶囊治疗强直性脊柱炎的效果,观察指标有腰臀痛程度、僵硬持续时间、红细胞沉降率(erythrocyte sedimentation rate,ESR)、C-反应蛋白(C-reactive protein,CRP)、ASAS 20改善标准,观察时间点为第1和第12周。在整个研究过程中,通过血液、肝脏和肾功能测试来监测安全性,并记录不良反应。结果 有60名患者参加了此次试验。①两组治疗均有效:补肾养骨口服液+塞来昔布胶囊组30例(80.3%),塞来昔布组30例(60.8%),两组的ASAS 20都达到改善标准;但补肾养骨口服液+塞来昔布胶囊组效果好于塞来昔布组(P<0.05)。②两组监测指标(腰臀痛程度、僵硬持续时间、ESR、CRP)对比,治疗后改善显著,而且补肾养骨口服液+塞来昔布胶囊组比塞来昔布组改善更明显。③两组治疗前后血常规、肝肾功能未见异常,但补肾养骨口服液+塞来昔布胶囊组不良反应发生率12.5%,而塞来昔布组为52.5%,两组差异具有统计学意义(P<0.05)。结论 本研究说明了补肾养骨口服液在治疗强直性脊柱炎中具有疗效,且较安全。
临床诊疗

四通道FES对脑卒中患者下肢运动功能影响的随机对照研究

:97-100
 
目的 观察四通道FES对脑卒中患者下肢运动功能的影响,为其临床应用及推广提供依据。方法 将入组的49例脑卒中患者随机分为四通道FES组(17例)、单通道FES组(16例)和对照组(16例),三组患者均进行(除电刺激)综合康复训练,四通道FES组模仿正常人行走时肌肉收缩的时序刺激患侧下肢的股四头肌、胫骨前肌、腓肠肌及腘绳肌。单通道FES组患者仅在迈步时刺激患侧下肢的胫骨前肌,而股四头肌、腓肠肌、腘绳肌三块肌肉仅作安慰刺激。对照组患者在上述四块肌肉处做安慰刺激(即仅在这四处肌肉贴电极片,但没有电流)。治疗时间为每周5次,持续2周共10次,在治疗前、治疗后1周、治疗后2周分别进行患侧下肢运动功能评定及平衡功能评估。结果 组内前后比较:两组患者治疗前、治疗后一周、治疗后两周下肢功能(FMA)及平衡功能(Berg)逐步提高(P<0.05)。组间比较:治疗后一周三组差异无统计学意义(P>0.05);治疗后两周三组有统计学意义,经过两两比较发现,只有四通道组与对照组之间差异有统计学意义(P<0.05),其他两组之间均无统计学意义。结论 应用基于正常行走模式四通道FES治疗可以改善患者的下肢功能及平衡功能。
论著

替诺福韦酯单药治疗慢性乙肝后肝硬化失代偿期的长期疗效随机对照研究

Randomized controlled study of long-term efficacy of tenofovir disoproxil monotherapy in the treatment of decompensated cirrhosis after chronic hepatitis B

:24-27
 
目的 探讨替诺福韦酯单药治疗在慢性乙型肝炎(CHB)后肝硬化失代偿期(DCC)治疗中的长期应用价值。方法 随机将84例CHB后DCC患者分为对照组及观察组,每组42例。对照组接受拉米夫定联合阿德福韦酯治疗,观察组接受替诺福韦酯治疗。对比两组12个月内治疗时间内的死亡率及肝癌发生率,并分析两组肝功能、肝硬化指标及Child-Pugh评分变化趋势,同时对比两组治疗过程中HBeAg转阴率、HBV-DNA转阴率及失代偿好转率。此外,对比两组治疗不良反应的发生率。结果 在12个月的治疗时间内,两组死亡率及肝癌发生率比较,差异无统计学意义(P>0.05)。而两组治疗过程中ALT、AST、HA、LN、PCⅢ及Child-Pugh评分呈降低趋势,ALB呈升高趋势(P<0.05);治疗6个月及12个月时,治疗组ALT、AST、HA、LN、PCⅢ及Child-Pugh评分低于对照组,ALB高于对照组(P<0.05)。而两组12个月治疗完成后,HBeAg转阴率比较差异无统计学意义,但观察组HBV-DNA转阴率高于对照组(P<0.05)。此外,两组治疗不良反应发生率比较差异无统计学意义(P>0.05)。结论 在CHB后DCC的治疗中,替诺福韦酯单药治疗方案具有良好的长期治疗效果。
Objective To evaluate the long-term value of tenofovir disoproxil monotherapy in the decompensated cirrhosis(DCC) after chronic hepatitis B(CHB). Methods Eighty-four patients with DCC after CHB were randomly divided into control group and observation group, 42 cases in each group. The control group received lamivudine combined with adefovir dipivoxil, and the observation group received tenofovir disoproxil. Mortality and incidence of liver cancer within 12 months of treatment between the two groups were compared, and the change trend of liver function, liver fibrosis index and child-pugh score in the two groups were analyzed. At the same time,we compared the conversion rate of HBeAg, HBV-DNA and decompensated positive rate between the two groups. In addition, the incidence of adverse reactions were compared between the two groups. Results Within 12 months of treatment, there were no statistically significant differences in mortality and liver cancer incidence between the two groups(P>0.05). And during the treatment, the ALT, AST, HA, LN, PC Ⅲ and Child-Pugh score showed a decrease trend, ALB showed a increase trend(P<0.05). After 6-month and 12-month treatment, ALT, AST, HA, LN, PC Ⅲ Child-Pugh score of treatment group were lower than that of control group, ALB was higher than that of control group(P<0.05). After 12 months of treatment, the negative conversion rate of HBV-DNA in the observation group was higher than that of control group(P<0.05). In addition, there was no statistically difference in the incidence of adverse reactions between the two groups(P>0.05). Conclusion Tenofovir disoproxil monotherapy has a good long-term therapeutic effect in the treatment of DCC after CHB.
临床诊疗

重组人表皮生长因子滴眼液联合玻璃酸钠治疗白内障术后干眼症的随机对照观察

Randomized controlled observation in recombinant Human epidermal growth factor eye drops combined sodium hyaluronate in treatment of xerophthalmia after cataract operation

:76-78
 
目的 探讨重组人表皮生长因子滴眼液联合玻璃酸钠治疗白内障术后干眼症的随机对照情况。方法 选取2017年度在本院实施白内障术后发生干眼症患者120例,采取随机分组方法分成观察组、对照组各60例,观察组给予重组人表皮生长因子滴眼液联合玻璃酸钠治疗,对照组给予玻璃酸钠滴眼液治疗,比较两组患者的临床疗效情况。结果 观察组有效率90%高于对照组73.33%,有差异;两组患者治疗前FL、BUT、SIT比较均无差异,P>0.05;治疗后,两组FL、BUT、SIT比较有差异,P<0.05; 两组患者治疗前视力评价比较均无差异,P>0.05;治疗后,两组视力评价比较有差异,P<0.05。结论 给予白内障术后干眼症患者采取重组人表皮生长因子滴眼液联合玻璃酸钠治疗,可提高临床疗效,对于改善相关临床体征、视力指标均具有重要临床价值。
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